Robert B Sullivan
Impact of device legislation
When Congress passed in 1962 the Kefauver-Harris amendments to the federal Food, Drug, and Cosmetic Act of 1938, the impact on the research and production of prescription drug products was shared by every member of the health care team. In 1975 Congress approved the Medical Device Amendments, and it is a safe assumption their enactment will have the same results. The operating room
Robert B Sullivan is vice-president of sales, medical-surgical division, Parke, Davis, and Co, Detroit. A graduate of the Massachusetts College o f Pharmacy, Boston, he is vice-president and a member of the Board of the Health Industry Manufacturers Association. Sullivan presented this paper before A O R N chapters in Omaha and Louisville. 658
n u r s h a l o n g with other health care professionals-will feel the impact in her areas of responsibility and in the future availability of products needed to provide better health care. It would be impossible in the space of a single article to cover the details of the present device legislation even if all areas had been clearly defined. As of now, there are many facets of the new legislation for which the Food and Drug Administration (FDA) has not yet developed formal plans. However, it is important to understand the general intent of the current Medical Device Amendments. The law requires that all devices be classified into three categories: Class I11 (premarket clearance)those subject to scientific review by the FDA prior to marketing Class I1 (standards)-those subject to performance standards Class I (controlled)-those for which general regulatory controls will be sufficient. Let’s take a quick look at what this categorizing of devices will mean. The Class I11 premarket clearance designation requires that all devices in this classification are subject to preclinical and premarket review. Evidence, including controlled clinical investigation, must be shown supporting the
AORN Journal, March 1977, V o l 2 5 , N o 4
effectiveness of the product. Nurses, physicians, hospitals, and other health care personnel and institutions will be asked to provide a considerable volume of supportive data for these devices. Investigational procedures have been published for review and some form will be adopted in the near future. Individuals and institutions becoming involved in these review programs will be, as manufacturers are, subject to FDA review to assure that the use application is as expected, that proper records are kept, and that patient consent was obtained in an acceptable manner. This is comparable to the requirements of private physicians, clinics, and institutions involved in the clinical trials of new prescription drug products. Until now medical device development has been a voluntary cooperative effort between developer and user. Will this relationship continue? Many individuals and institutions will not want to be involved in such closely controlled procedures and may choose not to continue their development assistance. The cost in delayed introduction time and the financial burden of these costly programs will obviously eliminate many existing and potential products. It is estimated that a well-controlled clinical study to support the safety and effectiveness of an existing product could cost $100,000. Obviously, a product must have considerable volume, a large profit margin, or both t o support this expense. Product and producer choices will be reduced. Although many products being placed in this category have been used for many years, they will not meet the new criteria. Record keeping will become more complex. Records of use will have to be
maintained that include product lot numbers used in the treatment of a particular patient. There is to be institutional peer review of the studies and initial justification, and it is proposed that no human research may be accomplished without an approved investigational device exemption from the FDA. This classification will undoubtedly include the smallest group of products under scrutiny. In conforming with the regulations affecting products in Class 11, we are faced with another set of problems. This group will be very large in number, and standard setting has not been effective. To conform to this process presents an endeavor that boggles the mind. It is doubtful that present resources in terms of personnel and laboratory time can cope with the task. Experience in standard setting has resulted in a siphoning effect on personnel and talent. The problem is also complicated by a difference of opinion between the FDA and the producers and users as to what constitutes a standard. Many of us believe the FDA is interested in promulgating rigid standards resembling specifications. This approach could lead to product stan. dardization and thus have a depressing effect on product innovation and creativity, and i t is bound t o stifle competition. On the other hand, standards concerned with performance characteristics of a product could be beneficial. Manufacturers, as well as those responsible for dispensing health care, would welcome an approach of this nature. The third category, Class I, requires general regulatory controls. General regulatory controls is a nonspecific term referring to those provisions of the existing Food, Drug, and Cosmetic Act already applying to devices, prod-
AORN Journal,March 1977, Vol25, No 4
659
C
ostly programs will eliminate many existing and potential products.
uct and manufacturer registration, factory inspection, submission of records and report, and adherence to good manufacturing practices. This category has the greatest impact on the manufacture of devices, particularly with reference to Good Manufacturing Practices. Recently, the FDA published for review and comment a draft set of Good Manufacturing Practices for medical devices. This draft did not reflect the current state of the art nor did it take into account the cost impact for compliance. In addition, it is debatable whether compliance with proposed Good Manufacturing Practices would really improve the safety and efficacy of medical devices. Adherence to the most exacting manufacturing practices cannot guarantee safety and effectiveness of a product. Safety and effectiveness limits are designed into a product as results of research and testing. Adhering to Good Manufacturing Practices regulations and product specifications can only assure that a manufacturer can repetitively produce a product that has the safety and effectiveness already built into its design. Good Manufacturing Practices regulations can realistically guide manufacturers by advising them of what is required in manufacturing practices. It cannot offer guidance as to how to accomplish the desired objective. The “how,” that is, the particular formats
660
and procedures, can vary significantly depending upon the method of manufacture chosen. Analogous to this situation would be a requirement in all operating room suites that only the closed glove technique could be used in donning surgeon’s gloves. What is important is that a procedure be used that will prevent contamination of the gloves; the technique or method used to accomplish this end is secondary. The Medical Device Amendments will raise many questions and considerations for individuals and institutions. Products often must be returned to the manufacturer for review and modification or replacement. Extensive regulations, which include FDA notification, contingency plans, and regulatory procedures, are being drafted for review and use. These methods will involve hospital personnel working closely with the producer to assure complete coverage and traceability. There will be many more incidents, and this increased activity will result in shortages as well as product elimination. Labeling and product claims present a number of challenges. Much more documentation will be required in this area. However, liability will be shifted or transferred in part to hospital personnel and will be a shared responsibility between developer and user. The development of proper labeling and
AORN Journal, March 1977, Vol25, No 4
product claims will increasingly involve hospitals and their personnel. Looking at other regulations, there is a proclamation concerning the hazards of ethylene oxide residues in or on products sterilized with ethylene oxide. FDA has published residual levels and aeration times. How many hospitals know the residue content of their ethylene oxide-sterilized products? Do they test these products after aeration? If they don’t, is this negligence? In an attempt to protect workers who handle vinylchloride, the FDA has restricted the amount of vinylchloride monomer allowed in polyvinylchloride film to less than one part per million. The characteristics of this film are now different. Many adjustments are still being made in specifications covering packaging, sealing, and other previously consistent properties. This has possibly been an overreaction, but to the user it has resulted in shortages and possible product elimination. The development of additional responsibility areas, personnel, laboratory facilities, and record systems to comply and keep abreast of these developments is one far-reaching implication of these regulations. Devices should be safe and effective. However, we must be cognizant of the dangers of overregulation, which can discourage innovation, interest, and creativeness, and eliminate healthy competition. For the manufacturer, user, and sometimes patient, it is obvious that the cost impact of compliance with these regulations will be significant. The sponsors of this act have often been questioned if they realize the additional and substantial increased cost of health care delivery as a result of this act. While there are various industry estimates in answer to the question, no one can estimate the true
costs of such programs and the inflationary effect as a result. Product costs will undoubtedly increase and inhouse compliance will result in additional personnel and increased manufacturing costs. Many of these additional expenses will be indirectly passed on to the patient. The mounting manufacturing costs imposed by current device legislation will surely force out of business some small manufacturers whose products are now in use. The cost of compliance cannot help but have a depressing effect upon competition. Reputable manufacturers would be the first to agree that quackery and quack products cannot be tolerated. Definitive legislation is essential. We welcome that aspect as essential and desirable and, with concern, will comply with all the act’s requirements to continue providing safe and effective products at the lowest cost possible. 0
AORN Journal, March 1977, Vol25, No 4
661
Impact of device legislation
When Congress passed in 1962 the Kefauver-Harris amendments to the federal Food, Drug, and Cosmetic Act of 1938, the impact on the research and production of prescription drug products was shared by every member of the health care team. In 1975 Congress approved the Medical Device Amendments, and it is a safe assumption their enactment will have the same results. The operating room
Robert B Sullivan is vice-president of sales, medical-surgical division, Parke, Davis, and Co, Detroit. A graduate of the Massachusetts College o f Pharmacy, Boston, he is vice-president and a member of the Board of the Health Industry Manufacturers Association. Sullivan presented this paper before A O R N chapters in Omaha and Louisville. 658
n u r s h a l o n g with other health care professionals-will feel the impact in her areas of responsibility and in the future availability of products needed to provide better health care. It would be impossible in the space of a single article to cover the details of the present device legislation even if all areas had been clearly defined. As of now, there are many facets of the new legislation for which the Food and Drug Administration (FDA) has not yet developed formal plans. However, it is important to understand the general intent of the current Medical Device Amendments. The law requires that all devices be classified into three categories: Class I11 (premarket clearance)those subject to scientific review by the FDA prior to marketing Class I1 (standards)-those subject to performance standards Class I (controlled)-those for which general regulatory controls will be sufficient. Let’s take a quick look at what this categorizing of devices will mean. The Class I11 premarket clearance designation requires that all devices in this classification are subject to preclinical and premarket review. Evidence, including controlled clinical investigation, must be shown supporting the
AORN Journal, March 1977, V o l 2 5 , N o 4
effectiveness of the product. Nurses, physicians, hospitals, and other health care personnel and institutions will be asked to provide a considerable volume of supportive data for these devices. Investigational procedures have been published for review and some form will be adopted in the near future. Individuals and institutions becoming involved in these review programs will be, as manufacturers are, subject to FDA review to assure that the use application is as expected, that proper records are kept, and that patient consent was obtained in an acceptable manner. This is comparable to the requirements of private physicians, clinics, and institutions involved in the clinical trials of new prescription drug products. Until now medical device development has been a voluntary cooperative effort between developer and user. Will this relationship continue? Many individuals and institutions will not want to be involved in such closely controlled procedures and may choose not to continue their development assistance. The cost in delayed introduction time and the financial burden of these costly programs will obviously eliminate many existing and potential products. It is estimated that a well-controlled clinical study to support the safety and effectiveness of an existing product could cost $100,000. Obviously, a product must have considerable volume, a large profit margin, or both t o support this expense. Product and producer choices will be reduced. Although many products being placed in this category have been used for many years, they will not meet the new criteria. Record keeping will become more complex. Records of use will have to be
maintained that include product lot numbers used in the treatment of a particular patient. There is to be institutional peer review of the studies and initial justification, and it is proposed that no human research may be accomplished without an approved investigational device exemption from the FDA. This classification will undoubtedly include the smallest group of products under scrutiny. In conforming with the regulations affecting products in Class 11, we are faced with another set of problems. This group will be very large in number, and standard setting has not been effective. To conform to this process presents an endeavor that boggles the mind. It is doubtful that present resources in terms of personnel and laboratory time can cope with the task. Experience in standard setting has resulted in a siphoning effect on personnel and talent. The problem is also complicated by a difference of opinion between the FDA and the producers and users as to what constitutes a standard. Many of us believe the FDA is interested in promulgating rigid standards resembling specifications. This approach could lead to product stan. dardization and thus have a depressing effect on product innovation and creativity, and i t is bound t o stifle competition. On the other hand, standards concerned with performance characteristics of a product could be beneficial. Manufacturers, as well as those responsible for dispensing health care, would welcome an approach of this nature. The third category, Class I, requires general regulatory controls. General regulatory controls is a nonspecific term referring to those provisions of the existing Food, Drug, and Cosmetic Act already applying to devices, prod-
AORN Journal,March 1977, Vol25, No 4
659
C
ostly programs will eliminate many existing and potential products.
uct and manufacturer registration, factory inspection, submission of records and report, and adherence to good manufacturing practices. This category has the greatest impact on the manufacture of devices, particularly with reference to Good Manufacturing Practices. Recently, the FDA published for review and comment a draft set of Good Manufacturing Practices for medical devices. This draft did not reflect the current state of the art nor did it take into account the cost impact for compliance. In addition, it is debatable whether compliance with proposed Good Manufacturing Practices would really improve the safety and efficacy of medical devices. Adherence to the most exacting manufacturing practices cannot guarantee safety and effectiveness of a product. Safety and effectiveness limits are designed into a product as results of research and testing. Adhering to Good Manufacturing Practices regulations and product specifications can only assure that a manufacturer can repetitively produce a product that has the safety and effectiveness already built into its design. Good Manufacturing Practices regulations can realistically guide manufacturers by advising them of what is required in manufacturing practices. It cannot offer guidance as to how to accomplish the desired objective. The “how,” that is, the particular formats
660
and procedures, can vary significantly depending upon the method of manufacture chosen. Analogous to this situation would be a requirement in all operating room suites that only the closed glove technique could be used in donning surgeon’s gloves. What is important is that a procedure be used that will prevent contamination of the gloves; the technique or method used to accomplish this end is secondary. The Medical Device Amendments will raise many questions and considerations for individuals and institutions. Products often must be returned to the manufacturer for review and modification or replacement. Extensive regulations, which include FDA notification, contingency plans, and regulatory procedures, are being drafted for review and use. These methods will involve hospital personnel working closely with the producer to assure complete coverage and traceability. There will be many more incidents, and this increased activity will result in shortages as well as product elimination. Labeling and product claims present a number of challenges. Much more documentation will be required in this area. However, liability will be shifted or transferred in part to hospital personnel and will be a shared responsibility between developer and user. The development of proper labeling and
AORN Journal, March 1977, Vol25, No 4
product claims will increasingly involve hospitals and their personnel. Looking at other regulations, there is a proclamation concerning the hazards of ethylene oxide residues in or on products sterilized with ethylene oxide. FDA has published residual levels and aeration times. How many hospitals know the residue content of their ethylene oxide-sterilized products? Do they test these products after aeration? If they don’t, is this negligence? In an attempt to protect workers who handle vinylchloride, the FDA has restricted the amount of vinylchloride monomer allowed in polyvinylchloride film to less than one part per million. The characteristics of this film are now different. Many adjustments are still being made in specifications covering packaging, sealing, and other previously consistent properties. This has possibly been an overreaction, but to the user it has resulted in shortages and possible product elimination. The development of additional responsibility areas, personnel, laboratory facilities, and record systems to comply and keep abreast of these developments is one far-reaching implication of these regulations. Devices should be safe and effective. However, we must be cognizant of the dangers of overregulation, which can discourage innovation, interest, and creativeness, and eliminate healthy competition. For the manufacturer, user, and sometimes patient, it is obvious that the cost impact of compliance with these regulations will be significant. The sponsors of this act have often been questioned if they realize the additional and substantial increased cost of health care delivery as a result of this act. While there are various industry estimates in answer to the question, no one can estimate the true
costs of such programs and the inflationary effect as a result. Product costs will undoubtedly increase and inhouse compliance will result in additional personnel and increased manufacturing costs. Many of these additional expenses will be indirectly passed on to the patient. The mounting manufacturing costs imposed by current device legislation will surely force out of business some small manufacturers whose products are now in use. The cost of compliance cannot help but have a depressing effect upon competition. Reputable manufacturers would be the first to agree that quackery and quack products cannot be tolerated. Definitive legislation is essential. We welcome that aspect as essential and desirable and, with concern, will comply with all the act’s requirements to continue providing safe and effective products at the lowest cost possible. 0
AORN Journal, March 1977, Vol25, No 4
661
